MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTR, CEMENT, POLY/METAL/POLY

Model Number	71453101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka performed on an unknown date.A revision surgery was performed to treat the adverse event.The lgn cr high flex xlpe sz 1-2 9mm was cracked.Subsequently the gii cm tib size 2 {} right was extracted.The locking mechanism of gii cm tib size 2 {} right is jeopardized.Further information is unknown at the moment.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be cracked along the surface, rendering the device inoperative.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that after a tka performed on an unknown date, a revision surgery was performed to treat the cracked lgn cr high flex xlpe sz 1-2 9mm.The gii cm tib size 2 right was also extracted because, it was felt that the locking mechanism might be jeopardized.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTR, CEMENT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15204140
• Report Number: 1020279-2022-03625
• Device Sequence Number: 17306275
• Product Code: JWH
• UDI-Device Identifier: 00885556033432
• UDI-Public: 00885556033432
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 71453101
• Device Catalogue Number: 71453101
• Device Lot Number: 10AM09935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420180 GII CM TIB SIZE 2 {} RIGHT.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown